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Myriad - Judge Sweet's opinion pp. 96-121, repost, with remaining notes. | 348 comments | Create New Account
Comments belong to whoever posts them. Please notify us of inappropriate comments.
Myriad - Judge Sweet's opinion pp. 96-121, repost, with remaining notes.
Authored by: macliam on Tuesday, April 09 2013 @ 06:03 PM EDT

Summary judgment is appropriate where the moving party has shown that “little or no evidence may be found in support of the nonmoving party's case. When no rational jury could find in favor of the no nm oving party because the evidence to support its case is so slight, there is no genuine issue of material fact and a grant of summary judgment is proper.” Gallo v. Prudential Residential Servs., L.P., 22 F.3d 1219, 1223-24 (2d Cir. 1994) (internal citations omitted).

B. 35 U.S.C. § 101 and Its Scope

Section 101 of Title 35, United States Code, provides:

Whoever invents or discovers any new and Useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

In interpreting this language, the Supreme Court has observed that “Congress plainly contemplated that the patent laws would be given wide scope.” Diamond v.

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Chakrabarty, 447 U.S. 303, 308 (1980); see also J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 131 (2001) (“[W]e are mindful that this Court has already spoken clearly concerning the broad scope and applicability of § 101.”).

However, this broad reading of § 101 and statutory patent eligibility is not without limits. “The Supreme Court has recognized that scientific principles and laws of nature, even when for the first time discovered, have existed throughout time, define the relationship of man to his environment, and, as a consequence, ought not to be the subject of exclusive rights to any one person.” In re Meyer, 688 F.2d 789, 795 (C.C.P.A. 1982) (citing Leroy v. Tatham, 55 U.S. 155, 175 (1852)). Specifically, the Supreme Court has recognized three categories of subject- matter that fall outside the scope of sect; 101: “The laws of nature, physical phenomena, and abstract ideas have been held not patentable.” Chakrabarty, 447 U.S. at 309; see also Diamond v. Diehr, 450 U.S. 175, 185 (1981). “The rule that the discovery of a law of nature cannot be patented rests, not on the notion that natural phenomena are not processes, but rather on the more fundamental understanding that they are not the kind of ‘discovery’ that the statute

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was enacted to protect.” Parker v. Flook, 431 U.S. 584, 593 (1918).

The exclusion of products of nature40 as patentable subject matter under § 101 also reflects the Supreme Court's recognition that ‘[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1912). Thus, as Justice Breyer has observed, “the reason for this exclusion is that sometimes too much patent protection can impede rather than ‘promote the Progress of Science and useful Arts,’ the constitutional objective of patent and copyright protection.” Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S, 124, 126-21 (2006) (Breyer, J.,

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dissenting) (quoting U.S. Const., Art. I, § 8, cl. 8.) (emphasis in original). For these reasons, “manifestations of laws of nature [are] free to all men and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).

The inquiry into an invention's patent eligibility is a fundamental one, and as such, “[t]he ob1igation to determine what type of discovery is sought to be patented must precede the determination of whether that discovery is, in fact, new or obvious.” Flook, 437 U.S. at 593; see also In re Bilski, 545 F.3d 943, 950 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (2009) (”Whether a claim is drawn to patent-eligible subject matter under § 101 is a threshold inquiry, and any claim of an application failing the requirements of § 101 must be rejected even if it meets all of the other legal requirements of patentability.” (citing In re Comiskey, 499 F.3d 1365, 1372 (Fed. Cir. 2007)); Prometheus Labs. v. Mayo Collaborative Servs., 581 F.3d 1336, 1343 (Fed. Cir. 2009) (noting that in determining patent eligibility, “it is improper to consider whether a claimed element or step in a process is novel or nonobvious, since such considerations are separate requirements set forth in 35 U.S.C. §§ 102 and

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103, respectively.” (citing Bilski, 545 F.3d at 958)). Consistent with this approach, the courts have rejected patent claims even when the purported invention was highly beneficial or novel, or the research and work that went into identifying it was costly or time-consuming. See, e.g., Funk Bros., 333 U.S. at 130; Am. Fruit Growers, Inc. v. Brodgex Co., 283 U.S. 1, 11-13 (1931); Gen. Elec. Co. v_ De Forest Radio Co., 28 F.2d 641, 642-43 (3d Cir. 1928).

The distinction between the § 101 inquiry into patentable subject matter and the other requirements for patentability set forth in Title 35 is of particular importance in evaluating the authorities cited by the parties and the arguments presented. The discussion of § 101 in In re Bergy, 596 F.2d 952 (C.C.P.A. 1979) by the late Honorable Giles S. Rich, one of the authors of the 1952 Patent Act, is particularly informative in clarifying the proper scope of a § 10l analysis. There, Judge Rich stated what considerations were salient—and importantly, what considerations were not—in a § 101 analysis:

Section 101 states three requirements: novelty, utility, and statutory subject matter. The understanding that these three requirements are separate and distinct is long-standing and has been universally accepted.… Thus, the questions of whether a particular invention is

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novel or useful are questions wholly apart from whether the invention falls into a category of statutory subject matter. Of the three requirements stated in § 101, only two, utility and statutory subject matter, are applied under § 101. As we shall show, in 1952 Congress voiced its intent to consider the novelty of an invention under § 102 where it is first made clear what the statute means by “new,” notwithstanding the fact that this requirement is first named in § 101.

Id. at 960-61 (emphasis added). Judge Rich further cautioned that “statements in the older cases must be handled with care lest the terms used in their reasoning clash with the reformed terminology of the present statute; lack of meticulous care may lead to distorted legal conclusions.” Id. at 959. The Supreme Court subsequently affirmed this understanding of the § 101 analysis in Diehr, noting that while it had been argued that “novelty is an appropriate consideration under § 101,” “[t]he question … of whether a particular invention is novel is ‘wholly apart from whether from whether the invention falls into a category of statutory subject matter.’” 450 U.S. at 189-90 (quoting Bergy, 596 F.2d at 961); see also _Bilski, 545 F.3d at 958 (“So here, it is irrelevant to the § 101 analysis whether Applicants' claimed process is novel or non- obvious.”).

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dissenting) (quoting U.S. Const., Art. I, § 8, cl. 8.) (emphasis in original). For these reasons, “manifestations of laws of nature [are] free to all men and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).

The inquiry into an invention's patent eligibility is a fundamental one, and as such, “[t]he ob1igation to determine what type of discovery is sought to be patented must precede the determination of whether that discovery is, in fact, new or obvious.” Flook, 437 U.S. at 593; see also In re Bilski, 545 F.3d 943, 950 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (2009) (”Whether a claim is drawn to patent-eligible subject matter under § 101 is a threshold inquiry, and any claim of an application failing the requirements of § 101 must be rejected even if it meets all of the other legal requirements of patentability.” (citing In re Comiskey, 499 F.3d 1365, 1372 (Fed. Cir. 2007)); Prometheus Labs. v. Mayo Collaborative Servs., 581 F.3d 1336, 1343 (Fed. Cir. 2009) (noting that in determining patent eligibility, “it is improper to consider whether a claimed element or step in a process is novel or nonobvious, since such considerations are separate requirements set forth in 35 U.S.C. §§ 102 and

102

As noted, the issue presented by the instant motions with regpect to the composition claims is whether or not claims directed to isolated DNA containing naturally-occurring sequences fall within the products of nature exception to § 101. Based upon the reasons set forth below, it is concluded that the composition claims- in-suit are excepted.

1. Consideration of the merits of Plaintiffs' challenge is appropriate.

Myriad offers several arguments for why this Court should not engage the substance of Plaintiffs' claims, but should instead dismiss them out of hand. Foremost among them is Myriad's assertion that Plaintiffs' claims should be dismissed in light of the “carefully considered policy of the USPTO,” which is “entitled to great respect from the courts.” Myriad Br. at 26. In so arguing, Myriad notes the presumption of validity afforded to patents, see 35 U.S.C. § 282, and the USPTO's prior consideration of the eligibility of gene-related patents, see Utility Examination Guidelines 66 Fed. Reg. 1092, 1092-99 (Jan. 5, 2001), as well as the Supreme Court's statements in J.E.M. Ag Supply, 534 U.S. 124.

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The Federal Circuit has previously held that it owes no deference to USPTO legal determinations. See, e.g., Arnold P'Ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004) (“This court reviews statutory interpretation, the central issue in this case, without deference.”). While Congress has created a presumption of validity for issued patents, approximately 40% of patents challenged in the courts have been found invalid, demonstrating that this presumption is far from absolute. See Institute for Intellectual Property & Information Law, University of Houston Law Center, Patstats.org, Full Calendar Year 2008 Report, http://www.patstats.org/2008_Full_Year_Posting.rev3.htm (indicating that 40% of all validity determinations in federal court in 2008 found the challenged patent invalid); Paul F. Morgan & Bruce Stoner, Reexamination v. Litigation — Making Intelligent Decisions in Challenging Patent Validity, 86 J. Pat. & Trademark Off. Soc'y 441-461 (2004) (citing USPTO statistics showing that 74% of patents previously issued by the Patent Office and later challenged through the reexamination process were either canceled or changed by the USPTO). Moreover, the lack of Congressional action to specifically prohibit gene patents in response to the USPTO's prior grant of such patents does not preclude

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their review by the courts. For example, in Bilski, 545 F.3d 943, the Federal Circuit set out a test for the patentability of method claims that potentially will invalidate thousands of patents on business method patents, degpite Congress' silence concerning the patentability of such methods. Finally, while the Supreme Court in J.E.M. Ag Supply noted the USPTO's practice of issuing patents on sexually reproducing plants in concluding that such plants represented patentable subject matter under § 101, that passing observation was neither dispositive nor central to the Court's holding and does not establish a rule of judicial deference to the USPTO's practices. See J.E.M. Ag _Supply, 534 U.S. at 144-45. Indeed, the judicial deference urged by Myriad is difficult to reconcile with the courts' consideration of the substantive issues presented in cases such as Chakrabarty and indeed, J.E.M. Ag Supply itself.

Moreover, in the absence of a § 101 challenge to patent validity, the fact that courts have previously upheld the validity of patents directed to biological products in response to § 102 and/or § 103 challenges has no bearing on the present inquiry. See e.g., In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (considering obviousness of claims); In re O'Farrell, 853 F.2d 894 (Fed. Cir. 1988)

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(same). The Patent Act sets out patent invalidity as an issue to be raised by the parties, see 35 U.S.C. § 282, and it would be erroneous to treat a case involving DNA-related patents as holding that isolated human genes constitute patentable subject matter under § 101. Were that the case, the Supreme Court could have proceeded with its consideration of Metabolite Labs., after it granted certiorari and the parties and amici had fully briefed the issue of patentable subject matter eligibility, rather than dismissing certiorari as improvidently granted based on the parties' failure to raise the § 101 issue below. 548 U.S. 124.

Finally, Myriad's suggestion that invalidating the patents-in-suit would constitute an unconstitutional taking in violation of the Fifth Amendment of the Constitution or a violation of the United States' obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is unpersuasive. Myriad's novel takings argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent. Similarly, Articles 8.1 and 27.3 of TRIPS permit governments to incorporate public health concerns into their intellectual property laws and

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to exclude from patentability diagnostic, therapeutic, or surgical methods as well as particular inventions on the grounds of public interest. As a result, invalidation of the patents-in-suit would constitute neither a constitutional violation nor a conflict with the United States' treaty obligations.

2. Patentable subject matter must be “markedly different” from a product of nature

Supreme Court precedent has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product. In American Fruit Growers, the Supreme Court rejected patent claims covering fruit whose skin had been treated with mold-resistant borax acknowledging that the “complete article is not found in nature,” and “treatment, labor and manipulation” went into producing the fruit, the Court nonetheless held that the fruit did not become an “article of manufacture” unless it “possesses a new or distinctive form, quality, or property” compared to the naturally-occurring article.41 283 U.S. at 11. The Court went on to observe:

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Manufacture implies a change, but every change is not manufacture, and yet every change in an article is the result of treatment, labor, and manipulation. But something more is necessary.… There must be transformation; a new and different article must emerge having a distinctive name, character, or use.

Id. at 12-13 (quoting Annheuser-Busch Brewing Ass'n v. United States, 207 U.S. 556, 562 (1908)) (internal citation and quotation marks omitted).

Similarly, in Funk Brothers, the Supreme Court considered whether a mixture of several naturally-occurring species of bacteria was patentable.42 333 U.S. at 128-31. Each species of bacteria in the mixture could extract nitrogen from the air for plant usage. While the patent holder had created a mixture by selecting and testing for strains of bacteria that did not mutually inhibit one

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another, the Court concluded that the patent holder “did not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.” Id. at 130.

Most recently, the Supreme Court addressed the application of § 101 to product claims in Diamond v. Chakrabarty, 447 U.S. 303. In Chakrabarty, the Court considered whether a “live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101.” Id. at 305. The microorganism in question was a bacterium that had been genetically engineered to break down multiple components of crude oil and possessed considerable utility in the treatment of oil spills. Id. In concluding that the man-made bacterial strain was patentable, the Court observed that the claim “is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character [and] use.’” Id. at 309-10 (quoting Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887)). The Court went on to contrast the Chakrabarty bacterium with the bacterial mixture at issue in Funk Brothers, stating that in Chakrabarty's case, “the patentee has produced a new bacterium with markedly

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different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own.…” Id. at 310.43 This requirement that an invention possess “markedly different characteristics” for purposes of § 101 reflects the oft-repeated requirement that an invention have “a new or distinctive form, quality, or property” from a product of nature. Am. Fruit Growers, 283 U.S. at 11; In re Merz, 97 F.2d 599, 601 (C.C.P.A. 1935) (“[M]ere purification of known materials does not result in a patentable product,” unless “the product obtained in such a case had properties and characteristics which were different in kind from those of the known product rather than in degree.”).

Courts have also specifically held that “purification” of a natural compound, without more, is insufficient to render a product of nature patentable. In The American Wood-Paper Co. v. The Fibre Disintearating Co., 90 U.S. (23 Wall.) 566 (1874), the Supreme Court held

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that refined cellulose, consisting of purified pulp derived from wood and vegetable, was unpatentable because it was “an extract obtained by the decomposition or disintegration of material substance.” Id. at 593. As the Court observed:

There are many things well known and valuable in medicine or in the arts which may be extracted from divers[e] substances. But the extract is the same, no matter from what it has been taken A process to obtain it from a subject from which it has never been taken may be the creature of invention, but the thing itself when obtained cannot be called a new manufacture.

Id. at 593-94.44 Similarly, in Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884), the Court rejected a patent on an artificial version of a natural red dye called alizarine that was produced by manipulating another compound through acid, heat, water or distillation. See generally, _id. Although the artificial version of the dye was of a brighter hue than the naturally occurring dye, the Court concluded that “[c]alling it artificial alizarine did not make it a new composition of matter, and patentable as such.…” Id. at 311 (citing Am. Wood-Paper, 90 U.S. (23 Wall.) at 593).

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In General Electric, 28 F.2d at 642, the Third Circuit Court of hppeals considered the patentability of purified tungsten, which possessed superior characteristics and utility over its brittle, naturally-occurring form. The court first noted that “[i]f it is a natural thing then clearly, even if [the patentee] was the first to uncover it and bring it into view, he cannot have a patent for it because a patent cannot be aHarded for a discovery or for a product of nature, or for a chemical element.” Id. The court went on to state:

Naturally He inquire who created pure tungsten. Coolidge? No. It existed in nature and doubtless has existed there for centuries. The fact that no one before Coolidge found it there does not negative its origin or existence.

The second part of the claim reads: “Having ductility and high tensile strength.” Did Coolidge give those qualities to “substantially pure tungsten”? We think not for it is now conceded that tungsten pure is ductile cold. If it possess that quality now it is certain that it possessed it always.

Id. at 643. The Court of Customs and Patent Appeals (“C.C.P.A.“), the precursor to the Federal Circuit Court of

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Appeals,45 subsequently relied on General Electric in rejecting patents claiming purified uraniwn and vanadium. See In re Marden, 47 F.2d 957, 957-58 (C.C.P.A. 1931) (“Marden I”); In re Marden, 47 F.2d 958, 1059 (C.C.P.A. 1931) (“Marden II”) (“The quality of purity of vanadium or its ductility is a quality of a natural product and as such is not patentable.”). Similarly, in Ex Parte Latimer, the Patent Commissioner refused to allow a patent on pine needle fibers that were better suited for textile production, even though it was necessary to remove the needle from its sheath and other resinous material. 1889 Dec. Comm'r Pat. 123, 125 (1889) (“Nature made them so and not the process by which they are taken from the leaf or needle.”).

Myriad argues that purification of “‘naturally occurring’ compounds that ‘do not exist in nature in pure form’ renders such compounds patent-eligible.” Myriad Br. at 21 (quoting In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A. 1970)). However, Myriad cites no Supreme Court

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authority that would rebut the authorities presented by Plaintiffs, nor do the cited cases support Myriad's position.

Myriad has relied heavily on the holding of the Honorable Learned Hand in Parke-Davis & Co. v. H.K. Mulford Co. 189 F.2d 95 (S.D.N.Y. 1911).46 In Parke-Davis, Judge Land considered a challenge to the validity of a patent

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claiming an adrenaline compound that had been isolated and purified from animal suprarenal glands. Id. at 97. It had been known that suprarenal glands in powdered form had hemostatic, blood-pressure-raising and astringent properties, but could not be used for those purposes in gross form. The isolated adrenaline, however, possessed the desired therapeutic properties and could be administered to humans.

Although Myriad argues that the holding in Parke-Davis establishes that the purification of a natural product necessarily renders it patentable, the opinion, read closely, fails to support such a conclusion. The question before the court in Parke-Davis was one of novelty (a modern-day § 102 question), not of patentable subject matter (the § 101 question before this Court). In framing the issue, Judge Hand observed that, “[the validity of the claims] is attacked, first, because they are anticipated in the art; and second, for a number of technical grounds which I shall take up in turn.” Id. at 101 (emphasis added). He went on to conclude that the patented purified extract was not, in fact, different from the prior art “only for a degree of purity,” but rather was a different chemical substance from that found in the prior art. Id.

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at 103 (observing that “no one had ever isolated a substance [adrenaline] which was not in salt form” and that “the [claimed] base [form of adrenaline] was an original production of [the patentee's]”). Thus, Judge Hand held that the purified adrenaline was not anticipated by the prior art, namely, the ground paradrenal gland that was known to possess certain beneficial properties. See Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156, 162 (4th Cir. 1958) (“It was further held [in Parke-Davis] that the invention was not anticipated, though the principle was known to exist in the suprarenal glands.”).

Only after concluding that the claimed purified adrenaline was novel over the prior art did Judge Hand Offer, as dicta, the statement to Which Myriad cites: “But, even if it were merely an extracted product without change, there is no rule that such products are not patentable.” Id. at 103. While the accuracy of this statement at the time was written is dubious in light of American Wood-Paper (to which Judge Hand did not cite) it is certainly no longer good law in light of subsequent Supreme Court cases, which, as noted above, require that a claimed invention possess “markedly different characteristics” over products existing in nature in order for it to constitute patentable

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subject matter.47 Chakrabarty, 447 U.S. at 310; see also Funk Bros., 333 U.S. at 130-32. By the same token, Judge Hand's suggestion that a claimed invention was patentable since it was a “new thing commercially and therapeutically,” Parke-Davis, 189 F.2d at 103, is firmly contradicted by subsequent case law establishing that “it is improper to consider whether a claimed element or step in a process is novel or nonobvious, since such congiderations are separate requirements” when evaluating whether a claim is patent-eligible subject matter. Prometheus, 581 F.3d at 1343; see also Bergy, 596 F.2d at 960-61. Such an approach would also be inconsistent with the Supreme Court's rejection of the patentability of the commercially useful mixture of bacteria in Funk Brothers, the refined cellulose in American Wood-Paper, and the electromagnetic communication devices in O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853).

The distinction between considerations of novelty and patentable subject matter similarly undermines Myriad's reliance on Bergstrom and In re Kratz, 592 F.2d 1169 (C.C.P.A. 1979), both of which presented issues of novelty

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and anticipation rather than the question of patentable subject matter. In Bergstrom, the C.C.P.A. considered an appeal from a rejection by the Board of Patent and Interferences (“BPAI”) of a patent claiming the purified rostaglandins PGE2 and PGE3 that had been extracted from human or animal prostate glands. 427 F.2d at 1398. Although the BPAI cited § 101 in its rejection, the C.C.P.A. recognized the issue as a § 102 question of novelty. Id. at 1400 (“Tested by the conventional evidentiary criteria or ‘conditions for patentability’ relevant to the present factual situation which Congress has expressed in the various provisions of 35 U.S.C. § 102, appellants are undoubtedly correct, for the Patent Office has not been able to … establish that the claimed subject matter lacks 'novelty.’”); see also id. at 1401 (“[T]he fundamental error in the board's position, as we see it, is the analysis and answer it gave to the sole issue it accurately posed - whether the claimed pure materials are novel as compared with the less pure materials of the reference.” (internal citation and uotation marks omitted)). Indeed, the C.C.P.A. itself has subsequently recognized that Bergstrom is properly viewed as a case concerning novelty. Bergy, 596 F.2d at 961 (“Our research has disclosed only two instances in which

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rejections for lack of novelty were made by the PTO under § 101.… In In re Bergstrom we in effect treated the rejection as if it had been made under § 102, obServing in the process that ‘The word “new” in § 101 is defined and to be construed in accordance with the provisions of § 102.’” (internal citation omitted)).

Kratz examined the rejection of a patent claiming a substantially purified chemical compound naturally occurring in strawberries, called 2-methyl-2-pentenoic acid (“2M2PA”). 592 F.2d at 1170. The patentee had appealed from the BPAI's determination that the purified compound was obvious over the prior art under § 103. See _id. Although there was some discussion about whether the composition claimed was a naturally-occurring compound, the C.C.P.A. did not view the question before it as a § 101 inquiry. Instead, the court treated the appeal as a question of novelty and anticipation pursuant to § 102.48 See, e.g., id. at 1174 (“It should be clear that an

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anticipation rejection in such a case is necessarily based on a dual footing.”).49

Finally, Merck & Co., Inc. v. Olin Mathieson Chem. Corp., 253 F.2d 156, cited by Myriad, is entirely consistent with the principle set forth in Funk Brothers and American Fruit Growers that something derived from a product of nature must “possess a new or distinctive form, quality, or property” in order to become patentable subject matter. Am. Fruit Growers, 283 U.S. at 11. In Merck, the Fourth Circuit considered the validity of a patent claiming a Vitamin B12 composition useful for treating pernicious anemia. Id. at 157. Although naturally occurring Vitamin B12 produced in cows had known therapeutic properties and was commercially available, the court found the purified B12 Compositipn, which was obtained from a microorganism, patentable. In upholding the validity of the patent, the court held:

Every slight step in purification does not produce a new product. What is gained may be the

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old product, but with a greater degree of purity. Alpha alumina purified is still alpha alumina, In re Ridgway, 76 F.2d 602,[] and ultramarine from which floatable impurities have been removed is still ultramarine, In re Merz, 97 F.2d 599 …

Id. at 163. Because the court concluded that the purified B12 was more than a “mere advance in the degree of purity of a known product,” it determined that the claimed invention was entitled to patent protection. Id. at 164.

In sum, the clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must pogsess “markedly different characteristics” in order to satisfy the requirements of § 101.

3. The claimed isolated DNA is not “markedly different” from native DNA

The question thus presented by Plaintiffs' challenge to the composition claims is whether the isolated DNA claimed by Myriad possesses “markedly different

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NOTES

40 Myriad distinguishes between “laws of nature,” ”natural phenomena,” and “abstract ideas,” which it concedes are not patentable, and “products of nature,” for which it appears to argue no prohibition to patentability exists. Although the digtinction between these two categories is unclear, it is well established that “products of nature” are not patentable. See e.g., Chakrabarty, 447 U.S. at 13 (stating that relevant distinction for § 101 patentability is “between products of nature, whether living or not, and human-made inventions”); Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641, 642 (3d Cir. 1928) (noting that “a patent cannot be awarded for a discovery or for a product of nature, or for a chemical element”); In re Marden, 47 F.2d 957, 957 (C.C.P.A. 1931) (concluding that “[u]ranium is a product of nature, and the appellant is not entitled to a patent on the same, or upon any of the inherent natural qualities of that metal”); In re Marden, 47 F.2d 958, 959 (C.C.P.A. 1931) (stating that “pure vanadium is not new in the inventive sense, and, it being a product of nature, no one is entitled to a monopoly of the same.”).

41 Myriad argues that American Fruit Growers was decided on novelty grounds, rather than subject matter patentability. See Myriad Br. at 26. However, the Court's novelty discussion was restricted to its analysis of the process claims. Am. Fruit Growers, 283 U.S. at 13-14 (“If it be assumed that the process claims under consideration cover an invention, we think this lacked novelty when application was made for the patent August 13, 1923”). In contrast, its rejection of the composition claims was based on an analysis of subject matter patentability. See id. at 11 (“Is an orange, the rind of which has become impregnated with borax, through immersion in a solution, and thereby resistant to blue mold decay, a ‘manufacture,’ or manufactured article, within the meaning of section 31, title 35, U.S. Code?”).

42 Myriad suggests that the Supreme Court's holding in Funk Brothers was premised on an obviousness determination, rather than patentable subject matter. Subsequent Supreme Court opinions, however, have treated the holding in Funk Brothers as a statement of patentable subject matter. See Chakrabarty, 447 U.S. at 309-lO; F1ook, 437 U.S. at 591-92; Benson, 409 U.S. at 67-68.

43 Although Chakrabarty is often cited for the proposition that “anything under the sun that is made by man” is patentable, id. at 309, that phrase is a misleading quotation from the legislative history of the Patent Act of 1952. The full quote clearly acknowledges the statutory limitations to patentable subject matter: “A person may have ‘invented’ a machine or a manufacture, which may include anything under the sun made by man, but it ig not necessarily patentable under section 101 unless the conditions of the title are fulfilled.” H.R. Rep. No. 1923, 82d Cong., 2d Sess. 6 (1952).

44 Given the posture of the challenge to the patent's validity, the Court rested its holding on the fact that the patent in question was invalid as non-novel. Id.

45 The decisions of the C.C.P.A. remain binding precedent in patent cases. See South CorD. v. Untted States, 690 F.2d J368, 1370-71 (Fed. Cir. 19B2) (en banc) (adopting “[t]hat body of law represented by the holdings of … the Court of Customs and Patent Appeals&rellip; as “precedent” for the then-new Federal Circuit so as to “continu[el the stability in those areas of the law previously within the jurisdiction of our predecessor courts”).

46 The invocation of Judge Hand is frequently practiced in this Circuit. See, e.g.,United States v. Rigas, 583 F.3d 108, 121 n.3 (2d Cir. 2009) (quoting Learned Hand for the proposition that appellate courts may not find facts); United States v. Parker, 554 F.3d 230 (2d Cir. 2009) (quoting Learned Hand for his formulation of the requirements of conspiracy); In re City of New York, 522 F.3d 279, 284 (2d Cir. 2008) (citing Learned Hand for hi9 formulation of negligence); In re Hyman, 501 F.3d 61, 67 (2d Cir. 2007) (quoting at length Learned Hand's inconclusive discussion of the meaning of the word “defalcation” in 11 U.S.C. § 523(a)(4)); United States v. Brand, 467 F.3d 179, 190 (2d Cir. 2006) (quoting Learned Hand's definition of inducement by the government); In re Enron Corp., 419 F.3d 115, 123 (2d Cir. 2005) (quoting Learned Hand's critique of statutes of limitations); Shannon v._Jacobowitz, 394 F.3d 90, 95 (2d Cir. 2005) (quoting Learned Hand's instruction that “[w]ords are not pebbles in alien juxtaposition.&ellip;”); Danahy v. Buscag1ia, 134 F.3d 1185, 1189 (2d Cir. 1998) (quoting Learned Hand on the rationale for qualified immunity). See a1so, Remarks of the Honorable John N. Walker, Jr. Upon Receiving the Learned Hand Meda1 for Exce11ence in Federal Jurisprudence, 76 St. John's L. Rev. 595, 596 (2002) (“Judge Hand is widely considered to have been one of the four greatest judges of the first half of the twentieth century.”); James L. Oakes, Personal Ref1ections on Learned Hand and the Second Circuit, 47 Stan. L. Rev. 387 (1995); Gerald Gunther, Learned Hand: the Man and the Judge (1994); Kathryn Griffin, Judge Learned Hand and the Ro1e of the Federa1 Judiciary (1973); Marvin Schick, Learned Hand's Court (1970); Marcia Nelson, ed., The Remarkable Hands: An Affectionate Portrait (1983); Hershel Shanks, ed., The Art and Craft of Judging: The Decisions of Judge Learned Hand (1968). Although Judge Hand once turned his back on the author of this opinion arguing before him on behalf of the Government, his opinion in Parke- Davis deserves careful review but brings to mind that oft repeated adage “Quote Learned, but follow Gus.” See Oakes, 47 Stan. L. Rev. at 389 n.175. This author, confronted by genomics and molecular biology, also emphatically empathizes with Judge Hand's complaint in Parke-Davis about his lack of knowledge of the rudiments of chemistry. See Parke-Davis, 189 F. at 114.

47 Notwithstanding Judge Hand's reputation, see supra note 46, his opinion in Parke-Davis was one of a district court judge and does not supersede contrary statements of the law by the C.C.P.A. or the Supreme Court.

48 The differences between the test applied in Kratz and the “markedly different” requirement set forth in Chakrabarty and other Supreme Court precedent further demonstrates that the Kratz court was engaged in a § 102 anticipation analysis and not a § 101 statutory subject matter analysis. See id. at 1174 (requiring, for a finding of anticipation, that “the natural composition must inherently contain the naturally occurring compound” and that “the claim must be of sufficient breadth to encompass both the known natural composition and the naturally occurring compound.”).

49 Bergy, also cited by Myriad, considered the question of whether microorganisms constituted patentable subject matter, an issue subsequently addressed by the Supreme Court in Chakrabarty. It did not address the patentability of purified natural products, and its citation to Merck and Parke-Davis was only for the purpose of noting that courts had upheld patents on pharmaceutical compounds such as vitamin B12 and adrenaline. See Bergy, 596 F.2d at 974-75 & n.13.

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